Post-Market Surveillance and Vigilance Requirements for European IVDs
30 May 2013 - 30 May 2013 - ON LINE
Surveillance and vigilance activities are critical for ensuring patient safety, and EU IVD manufacturers will soon be responsible for meeting new post-market requirements outlined in the draft IVD regulation. The revision of the IVDD has been an on-going process for some time and many in the industry are looking forward to a new, harmonized set of rules that aim to improve product safety and efficacy through increased post-market surveillance and vigilance reporting requirements. While these requirements are not final or expected to be adopted until 2014, many companies are anxious to implement appropriate policies and procedures and have greater collaboration and knowledge share with other manufacturers and member states.